To compare the efficacy and safety of dapsone versus atovaquone in preventing or delaying the onset of histologically proven or probable Pneumocystis carinii pneumonia in HIV-infected patients with CD4 counts <= 200 cells/mm3 or <= 15 percent of the total lymphocyte count who are intolerant to trimethoprim and/or sulfonamides. Trimethoprim/sulfamethoxazole (TMP/SMX), which is effective for secondary PCP prophylaxis, is associated with allergic manifestations and side effects that limit its use. Patients who are intolerant of TMP/SMX require an effective alternative. Dapsone and atovaquone have both shown promise as PCP prophylactic agents.

Condition	Treatment or Intervention	Phase
Pneumonia, Pneumocystis carinii HIV Infections	Drug: Atovaquone  Drug: Dapsone	Phase III

Further Study Details: 

Expected Total Enrollment:  700

Trimethoprim/sulfamethoxazole (TMP/SMX), which is effective for secondary PCP prophylaxis, is associated with allergic manifestations and side effects that limit its use. Patients who are intolerant of TMP/SMX require an effective alternative. Dapsone and atovaquone have both shown promise as PCP prophylactic agents.

Patients are randomized to receive either dapsone or atovaquone daily, with follow-up at the clinic every 4 months.

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Concurrent Medication: Strongly recommended:

• Pyrimethamine (50 mg) and folinic acid (15 mg) weekly in patients receiving dapsone who have CD4 count < 100 cells/mm3 and are toxoplasmosis seropositive.

Patients must have:

• Working diagnosis of HIV infection.
• CD4 count <= 200 cells/mm3 or <= 15 percent of total lymphocyte count at any time in the past OR a history of PCP.
• History of intolerance of trimethoprim and/or sulfonamides that required permanent discontinuation.

NOTE:

• Pregnant patients are eligible at the clinician's discretion.

Prior Medication: Allowed:

• Prior PCP prophylaxis.

Exclusion Criteria

Co-existing Condition: Patients with the following symptoms or conditions are excluded:

• Active pneumocystosis.

Concurrent Medication: Excluded:

• PCP prophylaxis (other than study drug) or any medication with potential anti-PCP activity.

Patients with the following prior conditions are excluded:

• Known treatment-limiting reaction to dapsone or atovaquone.

Alabama
      Univ of Alabama at Birmingham, Birmingham,  Alabama,  35294,  United States
      Dr John Dunkel, Huntsville,  Alabama,  35801,  United States
California
      Univ of California / San Diego Treatment Ctr, San Diego,  California,  921036325,  United States
      San Francisco Gen Hosp, San Francisco,  California,  941102859,  United States
      San Francisco AIDS Clinic / San Francisco Gen Hosp, San Francisco,  California,  941102859,  United States
      Stanford Univ Med Ctr, Stanford,  California,  943055107,  United States
      Summitt Med Ctr / San Francisco Gen Hosp, Oakland,  California,  94609,  United States
      Univ of Southern California / LA County USC Med Ctr, Los Angeles,  California,  900331079,  United States
      Children's Hosp of Los Angeles, Los Angeles,  California,  90027,  United States
      Community Consortium of San Francisco, San Francisco,  California,  94110,  United States
      Harbor UCLA Med Ctr, Torrance,  California,  90502,  United States
      San Mateo AIDS Program / Stanford Univ, Stanford,  California,  943055107,  United States
      Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium, San Jose,  California,  951282699,  United States
      Highland Gen Hosp / San Francisco Gen Hosp, Oakland,  California,  946021018,  United States
      Olive View Med Ctr, Sylmar,  California,  91342,  United States
      USC Univ Hosp & Ambulatory Hlth Care Ctr / USC Med Ctr, Los Angeles,  California,  900334508,  United States
Colorado
      Denver CPCRA / Denver Public Hlth, Denver,  Colorado,  802044507,  United States
      Univ of Colorado Health Sciences Ctr, Denver,  Colorado,  80262,  United States
      Denver Dept of Health and Hosps, Denver,  Colorado,  80262,  United States
      Kaiser Permanente Franklin Med Ctr, Denver,  Colorado,  80262,  United States
      Rose Med Ctr, Denver,  Colorado,  80262,  United States
Connecticut
      Yale Univ / New Haven, New Haven,  Connecticut,  065102483,  United States
District of Columbia
      Veterans Administration Med Ctr / Regional AIDS Program, Washington,  District of Columbia,  20422,  United States
      Howard Univ, Washington,  District of Columbia,  20059,  United States
      Georgetown Univ Med Ctr, Washington,  District of Columbia,  20007,  United States
      Whitman - Walker Clinic / Georgetown Univ Med Ctr, Washington,  District of Columbia,  200072197,  United States
      HIV Ctr - District of Columbia Gen Hosp, Washington,  District of Columbia,  200072197,  United States
Florida
      Univ of Miami School of Medicine, Miami,  Florida,  331361013,  United States
Georgia
      AIDS Research Consortium of Atlanta, Atlanta,  Georgia,  30308,  United States
      Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr, Atlanta,  Georgia,  303652225,  United States
Hawaii
      Queens Med Ctr, Honolulu,  Hawaii,  96816,  United States
      Univ of Hawaii, Honolulu,  Hawaii,  96816,  United States
Illinois
      Northwestern Univ Med School, Chicago,  Illinois,  60611,  United States
      Rush Presbyterian - Saint Luke's Med Ctr, Chicago,  Illinois,  60612,  United States
      AIDS Research Alliance - Chicago, Chicago,  Illinois,  60657,  United States
      Cook County Hosp, Chicago,  Illinois,  60612,  United States
      Louis A Weiss Memorial Hosp, Chicago,  Illinois,  60640,  United States
Indiana
      Indiana Univ Hosp, Indianapolis,  Indiana,  462025250,  United States
Iowa
      Univ of Iowa Hosp and Clinic, Iowa City,  Iowa,  52242,  United States
Louisiana
      Louisiana Community AIDS Research Program, New Orleans,  Louisiana,  70112,  United States
Maryland
      Johns Hopkins Hosp, Baltimore,  Maryland,  21287,  United States
      State of MD Div of Corrections / Johns Hopkins Univ Hosp, Baltimore,  Maryland,  212052196,  United States
Massachusetts
      Harvard (Massachusetts Gen Hosp), Boston,  Massachusetts,  02114,  United States
      Beth Israel Deaconess Med Ctr, Boston,  Massachusetts,  02215,  United States
      Boston Med Ctr, Boston,  Massachusetts,  02118,  United States
      Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial, Worcester,  Massachusetts,  01605,  United States
Michigan
      Henry Ford Hosp, Detroit,  Michigan,  48202,  United States
      Comprehensive AIDS Alliance of Detroit, Detroit,  Michigan,  48201,  United States
Minnesota
      Univ of Minnesota, Minneapolis,  Minnesota,  55455,  United States
      St Paul Ramsey Med Ctr, St. Paul,  Minnesota,  55101,  United States
      Hennepin County Med Clinic, Minneapolis,  Minnesota,  55415,  United States
Missouri
      St Louis Regional Hosp / St Louis Regional Med Ctr, St. Louis,  Missouri,  63112,  United States
Nebraska
      Univ of Nebraska Med Ctr, Omaha,  Nebraska,  681985130,  United States
New Jersey
      Robert Wood Johnson Med School / Hershey Med Ctr, New Brunswick,  New Jersey,  08903,  United States
      North Jersey Community Research Initiative, Newark,  New Jersey,  071032842,  United States
New York
      SUNY / State Univ of New York, Syracuse,  New York,  13210,  United States
      Univ of Rochester Medical Center, Rochester,  New York,  14642,  United States
      Bellevue Hosp / New York Univ Med Ctr, New York,  New York,  10016,  United States
      Mount Sinai Med Ctr, New York,  New York,  10029,  United States
      Jack Weiler Hosp / Bronx Municipal Hosp, Bronx,  New York,  10465,  United States
      Bronx Municipal Hosp Ctr/Jacobi Med Ctr, Bronx,  New York,  10461,  United States
      Montefiore Med Ctr / Bronx Municipal Hosp, Bronx,  New York,  10467,  United States
      Bronx Veterans Administration / Mount Sinai Hosp, Bronx,  New York,  10468,  United States
      SUNY / Erie County Med Ctr at Buffalo, Buffalo,  New York,  14215,  United States
      Harlem AIDS Treatment Group / Harlem Hosp Ctr, New York,  New York,  10037,  United States
      Beth Israel Med Ctr, New York,  New York,  10003,  United States
      SUNY / Health Sciences Ctr at Brooklyn, Brooklyn,  New York,  112032098,  United States
      Saint Clare's Hosp and Health Ctr, New York,  New York,  10019,  United States
      Columbia Presbyterian Med Ctr, New York,  New York,  100323784,  United States
      Adirondack Med Ctr at Saranac Lake, Albany,  New York,  122083479,  United States
      Mid - Hudson Care Ctr, Albany,  New York,  122083479,  United States
      Albany Med College / Division of HIV Medicine A158, Albany,  New York,  122083479,  United States
      Montefiore Adolescent AIDS Prog / Bronx Municipal Hosp, Bronx,  New York,  10461,  United States
North Carolina
      Carolinas Med Ctr, Charlotte,  North Carolina,  28203,  United States
      Univ of North Carolina, Chapel Hill,  North Carolina,  275997215,  United States
      Moses H Cone Memorial Hosp, Greensboro,  North Carolina,  27401,  United States
      Wake County Dept of Health, Raleigh,  North Carolina,  27610,  United States
Ohio
      Case Western Reserve Univ, Cleveland,  Ohio,  44106,  United States
      Ohio State Univ Hosp Clinic, Columbus,  Ohio,  432101228,  United States
Oregon
      Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland,  Oregon,  972109951,  United States
Pennsylvania
      Univ of Pennsylvania at Philadelphia, Philadelphia,  Pennsylvania,  19104,  United States
      Thomas Jefferson Univ Hosp, Philadelphia,  Pennsylvania,  191075098,  United States
South Carolina
      Julio Arroyo, West Columbia,  South Carolina,  29169,  United States
      Med Univ of South Carolina / UNC, Charleston,  South Carolina,  29425,  United States
Tennessee
      Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr, Knoxville,  Tennessee,  37920,  United States
      Vanderbilt Univ Med Ctr, Nashville,  Tennessee,  37203,  United States
Texas
      Univ of Texas Galveston, Galveston,  Texas,  775550435,  United States
Washington
      Univ of Washington, Seattle,  Washington,  981224304,  United States
Wisconsin
      Great Lakes Hemophilia Foundation, Wauwatosa,  Wisconsin,  532130127,  United States

Study chairs or principal investigators

El-Sadr W,  Study Chair
Luskin-Hawk R,  Study Chair
Murphy R,  Study Chair

Study ID Numbers:  ACTG 277; CPCRA 034
Record last reviewed:  July 2003
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000802
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08